Generic Drugs At 30: Fulfilling The Promise And Path Ahead

Law360, New York (July 24, 2014, 8:13 AM EDT) -- In the quest to reduce health care costs and to provide affordable medical care to patients, few events have been as significant as President Ronald Reagan signing into law the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act. Formally known as the Drug Price Competition and Patent Term Restoration Act, this watershed moment on Sept. 24, 1984, ushered in a new paradigm in the availability and use of prescription medicines in the United States. Seniors and others on fixed incomes were now able to afford needed drugs, and strict regulatory requirements guaranteed that those drugs were the bioequivalent counterparts of more expensive branded alternatives. Generic drug manufacturers, freed of having to perform lengthy, expensive clinical trials replicating those of brand drug manufacturers, and utilizing streamlined Abbreviated New Drug Application procedures, were encouraged by the prospect of a shorter pathway to the marketplace. Physicians, too, recognized that generic medicines offered all patients, regardless of income or wealth, the finest pharmacotherapies available. In the 30 years since that pivotal event, how far have generics come, and what are the challenges which lay ahead?...

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.


A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!